Understanding the crusade against e-cigarettes
If not licensed as a drug, the argument goes, all such products (other than cigarettes) should be summarily removed from the market.
The first letter urged the Food and Drug Administration to prohibit any non-drug product from claiming it offers “satisfaction” or a “nicotine hit,” as such claims should be considered drug claims. If enacted, such rules would require the product be removed from the market unless or until it is licensed as a drug.
The second letter to the FDA, related to their review of proposed regulations for e-cigarettes and selected other products, opines that drugs need to be tested both for safety and efficacy; non-drug tobacco-related products need to be tested only for potential harms. This note goes on to urge any such federal testing not be used to help commercialize any product.
Licensure as a drug requires blinded and randomized clinical trials. The product in question is compared to a placebo, with neither study participants nor investigators knowing which is which. Randomization is used to eliminate other factors that might affect the outcome. This works fine for medications used to treat diseases and can help determine short-term cure rates. It does not work very well for products intended to enable consumers to reduce their risk of potentially fatal disease by means of nonmedical changes in behavior.
E-cigarettes are intended to be recreational substitutes for cigarettes, to enable smokers to secure cigarette-like satisfaction without exposure to the deadly toxins in cigarette smoke. The e-cigarette products that seem to work best are those that enable users to pick the device, flavor and strength of nicotine that best meets their needs, and modify the flavor and strength of nicotine over time as they transition away from cigarettes. There is no practical way that this process can be studied by means of a randomized clinical trial. Imposing that as a requirement is simply a backhanded way to use the power to regulate to remove these products from the market.
As evidenced by its proposed regulations, FDA policy appears largely based on three considerations not written into either drug or tobacco laws. The first is that smoking is a disease, not a behavior. The second is a presumption that the only reason any non-pharmaceutical tobacco company would create a low-risk product would be to addict a new generation of teens to nicotine, with the expectation that they would then transition to cigarettes for a stronger and faster nicotine hit. The third is the notion that each new product and each product wishing a designation as lower in risk than cigarettes must provide original research comparing that individual product’s risk and addictiveness to cigarettes.
While some smokers are addicted to cigarette smoke, others are dependent on self-administered nicotine to enable them to properly focus on both work and enjoyable activities. Yet others simply enjoy an occasional smoke. The concept of smoking as a disease seems to be rooted in a brilliant marketing decision made by drug companies about 40 years ago that profits would be greater if they sell their nicotine gums, patches, etc. as drugs rather than as consumer products. No one in the public health community ever considered the possibility that anyone would ever develop a nicotine delivery product, like the e-cigarette, that could satisfy smokers without attracting significant numbers of teen nonsmokers to continuing nicotine use.
While governmental agencies can and have conducted large-scale surveys that demonstrate that e-cigarettes, as a class of products, attract very few nonsmoking teens to continuing nicotine use, it is physically impossible for the manufacturer of any single product (mass-market or vape shop) to demonstrate such non-recruitment in the context of a pre-market application. Imposing this requirement, as proposed by FDA, is another way to use the power to regulate to eliminate e-cigarettes from the marketplace.
Sensible regulation would enhance public health by giving smokers and potential smokers accurate information as to the risk and addictiveness presented by each class of nicotine-delivery product, while protecting all against shoddy manufacturing and predatory marketing.
The FDA’s proposed e-cigarette regulations will protect drug companies and cigarette makers from competition from these remarkable low-risk products. Eliminating them from the market, as currently anticipated, would deny us the opportunity to secure personal and public health benefits likely not achievable by any other means.
For those interested in more detail on the relative safety and relative non-addictiveness of e-cigarettes, compared to cigarettes, please see the Public Health England report, this safety evaluation by Dr. Konstantinos Farsalinos and this 2014 review by me.